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Harvard, MIT, Berkeley are still fighting over genome-editing patents. Now another ruling

Who says organic chemistry doesn't have its drama?

The US Patent Office's appeal board on Monday sided with Harvard University and MIT by upholding a set of the group's patents covering CRISPR-Cas9 genome editing in plants and animals.

CRISPR refers to a set of DNA sequences – Clustered Regularly Interspaced Short Palindromic Repeats – and the protein Cas9 is an enzyme that can cut DNA sequences. Research on CRISPR sequences dates back to 1993.

The foundational work on CRISPR-Cas9 gene editing in 2011 by Emmanuelle Charpentier, founder of the Max Planck Unit for the Science of Pathogens in Germany, and Jennifer Doudna, professor of Biomedical and Health at the University of California, Berkeley, proved significant enough to earn the 2020 Nobel Prize for Chemistry.

Doudna, Charpentier, Martin Jinek of UC Berkeley, and Krzystof Chylinski of the University of Vienna filed the first CRISPR-Cas9 patent application in May, 2012.

In December that year, researchers from The Broad Institute – a collaboration between Harvard University and MIT – filed their own patent application, and other patents have followed from multiple groups in the US, Europe, China, and other countries. According to Nature, the US Patent and Trademark Office (USPTO) last September had about 6,000 CRISPR patents or patent applications, with 200 added each month.

The Broad Institute was the first to be awarded a CRISPR patent, in April, 2014 (​​US Patent No. 8,697,359), based on work dating back to February 2011. According to the Broad Institute, its patent application was reviewed first and granted first because it requested "accelerated examination" and the UC group did not.

A set of Broad Institute patents were challenged in 2015 when the University of California, the University of Vienna, and Emmanuelle Charpentier (CVC) sought an interference proceeding to determine which group should be recognized as the inventor of the technology. CVC argued that details its researchers disclosed should invalidate subsequent Broad patent applications.

The USPTO began its interference proceeding in 2016, and in 2017 found that the Broad Institute's claims did not interfere with those made by CVC researchers. Following an appeal, the US Court of Appeals in 2018 affirmed that Broad Institute's patents were separately patentable and didn't overlap with what CVC claimed.

Then the USPTO initiated a second interference proceeding in 2019 covering 10 CVC CRISPR patents and 13 Broad Institute patents and one Broad patent application.

This second CVC-backed proceeding concluded on Monday with the USPTO's Patent, Trial and Appeal Board (PTAB) issuing a decision [PDF] that sides with the Broad Institute and against CVC.

"This decision once again confirmed Broad’s patents were properly issued," the Broad Institute said in a statement. "As the PTAB and US federal courts have repeatedly established, the claims of Broad’s patents to methods for use in eukaryotic cells, such as for genome editing, are patentably distinct and not reasonably expected from results of biochemical 'test tube' experiments."

The University of California, Berkeley, expressed unhappiness with the ruling, which doesn't affect more than 40 other CRISPR-related patents in the US, as well as patents in other countries.

"The University of California is disappointed by the PTAB’s decision and believes the PTAB made a number of errors," the university said in a statement. "CVC is considering various options to challenge this decision."

The Broad Institute patents at issue are also currently being challenged by biotech firms Toolgen and Sigma-Aldrich. ®

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